BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101)

    K Number: K210664 · Decision Jul 27, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    42
    Registration Numbers
    42
    Same Product Code
    56
    Applicant Total
    4
    Review Days
    144

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    Basic Information

    Device Name
    DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101)
    K Number
    K210664
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ra Medical Systems,Inc
    Date Received
    March 5, 2021
    Decision Date
    July 27, 2021
    Product Code
    PDU
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PDU Catheter For Crossing Total Occlusions

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    Other Clearances by Ra Medical Systems,Inc

    K Number Device Name
    K220544 DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0)
    K170349 RA-308 Excimer Laser System, Excimer Laser Catheter
    K062963 PHAROS EXCIMER LASER SYSTEM, MODEL EX-308